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Experience with analytical instrumentation, such as HPLC, GC, CE, ICP, FTIR, and dissolution apparatus in a GMP environment. Understand and run HPLC, GC, ICP, UV, FTIR, Dissolution tester, and other analytical instrumentation in an analytical lab setup.
$80,000 - $90,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Immunology, Laboratory, biochemistry, glp, gmp, biology, elisa, antibodies, aseptic technique, iso 13485, Chemistry, assay development, assay. immunology, Laboratory, biochemistry, glp, gmp, biology, elisa, antibodies, aseptic technique, iso 13485, Chemistry, assay development, assay.
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Experience with Tech transfer to CDMO for non-GMP and GMP manufacturing, including cell line development, process development, analytical method development and manufacturing scale up. Experience with Tech transfer to CDMO for non-GMP and GMP manufacturing, including cell line development, process development, analytical method development and manufacturing scale up.
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We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director of GMP Quality Control, who oversees GMP compliance of manufacturing, testing and release activities for SMPA, its partners, contract testing laboratories, and suppliers of drug substances and drug products used for investigational clinical trials and/or commercial phases.
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Dynamic individual with lots of GMP Data Validation experience with core experience in TIBCO (Spotfire, Statistica) , OSIPi, Snowflake and other data tools. TIBCO (Spotfire, Statistica) , OSIPi/OSISoft, Snowflake and other data tools Experience: 3 years.
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Associate Director, GMP Quality Control. Experience in evolving GMP related quality systems, policies, and procedures to ensure compliance with evolving standards as well as improving the efficiency of related workflows.
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Lead and/or present at the Stability and Specification Review Committees for GMP Drug Substance and Drug Product programs. Advanced knowledge of GMP manufacturing and/or market release of pharmaceutical dosage forms and/or combination products desired.
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Experience desired with drug delivery devices, diagnostics, biomarker, and genetic testing. Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies.
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Experience working in more than one product area (e.g. solid oral dose, injectables, combination products), and therapeutic area (e.g. oncology, urology, regenerative medicine) within Quality Control a plus.
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Under the supervision of the Director of the Human Gene and Cell Therapy Facility (HGCTF), the HGCTF Lead Manufacturing Associate is responsible for the manufacturing of human gene and cell therapy products under Good Manufacturing Practices (GMP), quality control testing of these products to ensure that the products meet the required quality, supervise other manufacturing associates and overall management of all projects.
$6,566.67 - $14,583.33 a monthFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Expected to adhere to safe work practices, follow GMP and HACCP guidelines, maintain sanitary conditions and ensure that product quality is maintained in order to maintain SQF Level 3 certification.
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Location Description: Michael Foods, Inc. located in Klingerstown, Pennyslvania known for their ice cream socials at Klingerstown Lutheran Parish, fishing rodeo, and fireman's parade. Michael Foods, Inc. is a leader in the food processing and distribution industry with business in egg products, refrigerated grocery and potato products.
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With paid media execution, ad tech (GMP), tracking & analytics, dashboard creation (e. with D2C counterparts such as Sales, Go-To-Market, Product Management, dXp DTC, Growth Marketing, Email Marketing, Data Ops, Tech Dev, and Creative teams.
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They also monitor the facility operation to ensure compliance with corporate quality requirements, SQF, labeling, GMP s, food safety, and all other such standards of the plant. The QA Technician will be an example for the line, as such they will need to be honest, dependable, punctual, and trustworthy and follow all policies/procedures set forth by Shearers Foods LLC. The QA Technician must have the ability to work well with others.
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Project lead for establishing Pilot Plant operations including building out the team to support process scale-up, implementation of new processes, and execution at GMP scale. Optimize pilot plant and pre-clinical production performance to allow for fast, flexible processing of multiple manufacturing processes including plasmid DNA prep, mRNA transcription and purification, and LNP formulation, and oligonucleotide synthesis.
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